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Sargramostim in Patients With Acute Hypoxic Respiratory Failure Due to COVID-19 (SARPAC)

NCT04326920 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2022-11-16

Study results available
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Summary

Phase IV study to evaluate the effectiveness of additional inhaled sargramostim (GM-CSF) versus standard of care on blood oxygenation in patients with COVID-19 coronavirus infection and acute hypoxic respiratory failure.

Conditions

Interventions

DRUG

Sargramostim

Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration

OTHER

Control

Standard of care

Sponsors & Collaborators

  • Flemish institute of biotechnology (VIB)

    collaborator OTHER

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Bart Lambrecht · University Hospital, Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-24
Primary Completion
2020-09-28
Completion
2021-02-26
FDA Drug
Yes

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04326920 on ClinicalTrials.gov